| CTRI Number |
CTRI/2018/08/015191 [Registered on: 06/08/2018] Trial Registered Prospectively |
| Last Modified On: |
06/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study To Compare Effect of Extent Of Resection of Stomach During Laproscopic Sleeve Gastrectomy For Morbidly Obese |
|
Scientific Title of Study
|
A Prospective, Randomised Controlled Study To Compare Antral Resection Versus Antral Preservation During Laproscopic Sleeve Gastrectomy For Morbidly Obese |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devender Singh |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Departrment of Surgical Disciplines, AIIMS, NEW DELHI
Departrment of Surgical Disciplines, AIIMS, NEW DELHI
North
DELHI
110029
India |
| Phone |
9813643337 |
| Fax |
|
| Email |
devinderkuntal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Aggarwal |
| Designation |
Senior Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Departrment of Surgical Disciplines, AIIMS, NEW DELHI
Departrment of Surgical Disciplines, AIIMS, NEW DELHI
North
DELHI
110029
India |
| Phone |
9810235580 |
| Fax |
|
| Email |
sandeep_aiims@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Aggarwal |
| Designation |
Senior Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Departrment of Surgical Disciplines, AIIMS, NEW DELHI
Departrment of Surgical Disciplines, AIIMS, NEW DELHI
East
DELHI
110029
India |
| Phone |
9810235580 |
| Fax |
|
| Email |
sandeep_aiims@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
DEPARTMENT OF SURGICAL DISCIPLINES, 5TH FLOOR, AIIMS, NEW DELHI |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devender Singh |
AIIMS, NEW DELHI |
Department of Surgical Disciplines
North
DELHI |
9813643337
devinderkuntal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR, NEW DELHI 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
MORBID OBEISITY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antrum preservation laproscopic sleeve gastrectomy |
Sleeve of stomach will be created at 5 cm from pylorus |
| Intervention |
Antrum resection laproscopic sleeve gastrectomy |
Sleeve of stomach will be created at 2 cm from pylorus |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Includes accepted indications for bariatric surgery like
1.Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with atleast one co-morbidity associated with obesity (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea)
2.Age between 20 and 60years
3.Failure of conservative treatment over2 years.
|
|
| ExclusionCriteria |
| Details |
1.Significant GERD symptoms
2.Erosive esophagitis on UGIE
3.Poorly controlled significant medical or psychiatric disorders
4.Active alcohol or substance abuse
5.Active duodenal/gastric ulcer disease
6.Previous major gastrointestinal surgery
7.End-stage organ disease
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent excess weight loss |
3, 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Gastric emptying time
2.GERD symptoms
3.Weight regain
4.Post operative staple line bleed
5.Staple-line leak
6.30-day mortality |
3,6 and 12 months (Gastric emptying time at 0 and 12 months) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/08/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Bariatric or Metabolic surgery has emerged as an effective and durable treatment for morbidly obese as it induces good weight loss,decreased comorbidities like Diabetes and hypertension and gives a better quality of life. Laproscopic Sleeve gastrectomy is one of the type of various surgeries done for morbidly obese patients but there are various controversies regarding the operating technique such as the size of the bougie used, distance of pylorus from the staple line,reinforcement of staple line and use of intraoperative seal test. Our study will deal with one of the debatable issue that is the distance of pylorus from staple line. Patient will be randomised in two groups i.e Antral preservation (5 cm from pylorus) and Antral resection (2cm from the pylorus) and the outcomes will be measured at 0, 3,6 and 12 months in terms of weight loss as primary outcome and comorbidity resolution , complication and gastric emptying time as secondary outcome. |